On Fri, 12 Mar 2004 09:08:31 -0800, Richard Nute <[email protected]> wrote:
> Have you tried to understand this requirement??? > > > Page 35 > 60601-1-2 IEC:2001(E) > > ***** > > *36.202.1 GENERAL > > *d) Non-medical electrical equipment > > Non-medical electrical equipment that is supplied as part of > a SYSTEM and the use of which in the SYSTEM can be reasonably > expected not to affect the ESSENTIAL PERFORMANCE or safety of > the SYSTEM if the non-medical electrical equipment exhibits > DEGRADATION, is exempt from the IMMUNITY testing requirements > of this standard, provided the non-medical electrical equipment > complies with applicable international IMMUNITY standards. > (For example see CISPR 24 for ITE and IEC 61326-1 for > measurement, control and laboratory equipment.) The > determination of reasonable expectation not to affect the > ESSENTIAL PERFORMANCE or safety of the SYSTEM shall be based > upon a risk analysis. This risk analysis is not required if > the non-medical electrical equipment supplied as part of a > SYSTEM is tested for IMMUNITY in accordance with 36.202. ... > Worse still, the equipment is NEVER exempt from immunity > testing -- which was the original statement! The > statement boils down to: > > The equipment must either be tested alone or > as a part of a system. I think it is partially true, but an important point here is that two immunity requirements are referenced in the clause: that of IEC 60601-1-2, and that of applicable international standards such as CISPR 24, IEC 61326, etc. If risk analysis shows use of the non-medical equipment would not affect the essential performance or safety of the system, and if the equipment complies with the immunity requirements of the applicable standards, the equipment don't have to comply with the immunity requirements of 60601. If no risk analysis applied, we should think that the equipment may affect the essential performance or safety of the system, and we may need to test the equipment for immunity in acoordance with the requirements of 60601. In the other hand, if we test the equipment for immunity in acoordance with the requirements of 60601, we don't have to show that the equipment would not affect the essential performance or safety of the system, hance no risk analysis would not be required here. That is what the clause of the standards says, I think. Regards, Tom Tomonori Sato <[email protected]> URL: http://homepage3.nifty.com/tsato/ This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
